FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUBEAD THYROID UPTAKE
K Number: K872172
·
Decision Aug 17, 1987
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
92
Applicant Total
37
Review Days
70
Basic Information
- Device Name
- IMMUBEAD THYROID UPTAKE
- K Number
- K872172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- IMMUNOTECH CORP.
- Date Received
- June 8, 1987
- Decision Date
- August 17, 1987
- Product Code
- KHQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
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| K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES | May 5, 1995 | Substantially Equivalent |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Oct 22, 1993 | Substantially Equivalent |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | Jun 24, 1991 | Substantially Equivalent |
| K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT | Jun 18, 1991 | Substantially Equivalent |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Apr 3, 1991 | Substantially Equivalent |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | Dec 20, 1990 | Substantially Equivalent |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |